incidence and severity of adverse events [ Time Frame: for an average of 3 years ] [ Designated as safety issue: Yes ]

bleeding by BARC definition [ Time Frame: for an average of 3 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction

Official Title ICMJE

The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.

Brief Summary

This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction(</=45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.

Bone marrow-derived progenitor cells are obtained from 50ml bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique

Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion

Exclusion Criteria:

Participation in another clinical trial within 30 days prior randomisation

Previously received stem/progenitor cell therapy

Pregnant or nursing women

Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol

Necessity to revascularise additional vessels, outside the target coronary artery at the time of progenitor cell infusion (additional revascularisations before, e.g. at the time of acute PCI, are permitted)allowed), unless clinically indicated and according to latest guidelines. This decision should be made at the time of the index procedure and explicitly stated at that time.